GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
Reported: January 21, 2015 Initiated: September 15, 2014 #Z-0841-2015
Product Description
GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
Reason for Recall
mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3).
Details
- Recalling Firm
- GE OEC Medical Systems, Inc
- Units Affected
- 61 units installed in US
- Distribution
- Worldwide Distribution
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.. Recalled by GE OEC Medical Systems, Inc. Units affected: 61 units installed in US.
Why was this product recalled? ▼
mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 21, 2015. Severity: Moderate. Recall number: Z-0841-2015.
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